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Draft Standard Operating Procedures

In clinical research, standard operating procedures (SOPs) help define the standard practices and daily processes that are conducted to assure execution of research tasks in accordance with the research protocol and institutional, state and federal guidelines.

SOPs should contain enough detail to guide research staff through a particular procedure, and thereby establish uniformity in the everyday functions related to that study.

SOPs should contain specifically defined procedures that can be followed without deviation and commonly include:

  • Good Clinical Practice (GCP) training
  • Delegation of responsibilities and authority to research staff members
  • Subject screening and recruitment
  • Informed consent process and documentation
  • Subject eligibility confirmation
  • Source documentation
  • Data management
  • Protocol deviations
  • Adverse events and serious adverse events reporting
  • Confidentiality of information
  • Drug/device storage, accountability and management
  • Regulatory document submissions (initial, amendments and continuing reviews)
  • Sample processing and shipping training
  • Monitoring visits
  • Sponsor, contract research organization (CRO) and internal audits
  • Food and Drug Administration (FDA) audits
  • Record organization and retention
  • Sub-site management

Learn More

The Division of Clinical Research (DCR) at Massachusetts General Hospital helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCR programs are noted in parentheses.




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